Not-Quite Prior Art Supports Obviousness Of Copaxone Patents In IPR Proceedings

In Yeda Research & Development Co., v. Mylan Pharmaceuticals Inc., the Federal Circuit affirmed the decisions of the USPTO Patent Trial and Appeal Board (PTAB) finding three Copaxone patents invalid as obvious in parallel Inter Partes review (IPR) proceedings. The companion decision pertaining to related district court litigation caught my attention for its use of originally confidential statements to FDA as evidence of the state of the art that supported obviousness. This decision caught my attention for its use of a study published three weeks after the priority date as evidence of the motivation and reasonable-expectation-of-success elements of obviousness.

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USPTO Addresses IDS PTA Deduction Error

The USPTO has devised a plan to address the IDS PTA deduction error that incorrectly charges a Patent Term Adjustment (PTA) deduction for Information Disclosure Statements (IDSs) filed with a “safe harbor” statement. Although the USPTO won’t be able to correct the underlying problem until it rolls out its “next generation” information technology systems, it has devised a plan to make it easier for applicants to flag safe harbor IDSs, and easier–and cheaper–to request recalculation of a PTA award when this is the only error.

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USPTO Access To Relevant Prior Art Initiative

In an October 25, 2018 Federal Register Notice, the USPTO announced staged implementation of the first phase of an initiative aimed at “leveraging electronic resources to retrieve information” of record in one patent application for consideration in another. While the first phase of the Access to Relevant Prior Art Initiative is limited to importing citations from a parent application into its immediate child, it represents an important first step towards reducing the burdens of satisfying the Duty of Disclosure.

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Invalidity Of Copaxone Patents Supported By Statements To FDA

In In re Copaxone Consolidated Cases, the Federal Circuit affirmed the district court decision finding four patents directed to a specific dosing regimen for using COPAXONE® 40 mg/ml to treat patients with relapsing multiple sclerosis invalid as obvious. One thing that caught my attention was the use of originally confidential statements to FDA as evidence of the state of the art that supported the obviousness holding.

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Don't Touch That Priority Claim!

In Natural Alternatives Intl. Inc. v. Iancu, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that the patent at issue was not entitled to its earliest claimed priority date because NAI had deleted priority claims in a parent application that broke the priority chain. This decision highlights that a priority claim chain must be continuous and remain unbroken in order for a priority claim to be valid.

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